ParagangliomasDOTATATENCT02186678
Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
A study testing PET-CT in people with Paragangliomas and Pheochromocytomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Paragangliomas, Pheochromocytomas
- What is being tested?
- PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2014to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- PHEO or PGL: initial staging or restaging
- Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization
Who cannot join
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.
In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
- Conditions
- Paragangliomas, Pheochromocytomas
- Being tested
- PET-CT
- Medical subject headings
- Paraganglioma, Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTOther
| Study group | Role | What they receive |
|---|---|---|
| assesment by 68Ga-DOTATATE PET-CT | Experimental | Not described Receives: Other: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.
Measured: 7 months
Secondary outcomes (1)
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study start18 Jul 2014
- Primary completion5 Oct 2015
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParagangliomasStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David TAIEB, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186678
- Sponsor's protocol ID
- 2013-26
- Acronym
- DOTATATE
- Status last verified
- Apr 2023
- First submitted
- 4 Jun 2014
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
- ClinicalTrials.gov ID
- NCT02186678
- Acronym / sponsor ID
- DOTATATE / 2013-26
- Conditions
- Paragangliomas, Pheochromocytomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- 5 Oct 2015 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.
In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assesment by 68Ga-DOTATATE PET-CT | Experimental | Other: PET-CT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- PHEO or PGL: initial staging or restaging
- Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization
Key exclusion criteria (1 listed)
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CT | Other | assesment by 68Ga-DOTATATE PET-CT |
Primary outcome
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
Time frame: 7 months
The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.
1 secondary outcome
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David TAIEB, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT in people with Paragangliomas and Pheochromocytomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.